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DRUG:

leuprolide acetate for depot suspension

i
Other names: TAP-144-SR, TAP-144SR, TAP-144, TAP-144-SR (6M), DWJ 108J, PT105
Company:
Generic mfg.
Drug class:
GnRH agonist
14d
Enzalutamide Versus Standard Androgen Deprivation Therapy for the Treatment Hormone Sensitive Prostate Cancer (clinicaltrials.gov)
P2, N=19, Active, not recruiting, University of Colorado, Denver | Trial completion date: Apr 2024 --> Apr 2025
Trial completion date
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Xtandi (enzalutamide capsule) • triptorelin • goserelin acetate • Firmagon (degarelix) • leuprolide acetate for depot suspension
17d
New P3 trial
|
Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension
17d
REPLACE-CV: Randomized Study to Evaluate MACE in Patients With Prostate Cancer Treated With Relugolix or Leuprolide Acetate (clinicaltrials.gov)
P3, N=2250, Active, not recruiting, Sumitomo Pharma Switzerland GmbH | Trial completion date: Feb 2027 --> Dec 2024 | Trial primary completion date: Feb 2027 --> Dec 2024
Trial completion date • Trial primary completion date • Adverse events
|
Orgovyx (relugolix) • leuprolide acetate for depot suspension
26d
Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed Tumors (clinicaltrials.gov)
P2, N=60, Active, not recruiting, Xiao X. Wei, MD | Recruiting --> Active, not recruiting
Enrollment closed • Combination therapy • Metastases
|
PD-L1 (Programmed death ligand 1) • BRCA1 (Breast cancer 1, early onset) • MSI (Microsatellite instability) • CD8 (cluster of differentiation 8) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2) • CDK12 (Cyclin dependent kinase 12) • CHEK2 (Checkpoint kinase 2) • BRIP1 (BRCA1 Interacting Protein C-terminal Helicase 1) • RAD51C (RAD51 paralog C) • RAD51D (RAD51 paralog D) • NBN (Nibrin Nijmegen Breakage Syndrome 1 (Nibrin)) • ABRAXAS1 (Abraxas 1 BRCA1 A Complex Subunit 2) • GEN1 (GEN1 Holliday junction 5' flap endonuclease)
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PD-L1 expression • MSI-H/dMMR
|
OncoPanel™ Assay
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Opdivo (nivolumab) • docetaxel • goserelin acetate • Firmagon (degarelix) • leuprolide acetate for depot suspension
26d
Real World Evidence Study on Metastatic Prostate Cancer in the Pirkanmaa Hospital District in Finland (clinicaltrials.gov)
P=N/A, N=1, Completed, Pfizer | Trial completion date: Jun 2023 --> Apr 2024 | Trial primary completion date: Jun 2023 --> Apr 2024
Trial completion date • Trial primary completion date • HEOR • Real-world evidence • Real-world • Metastases
|
docetaxel • Xtandi (enzalutamide capsule) • abiraterone acetate • cabazitaxel • Erleada (apalutamide) • triptorelin • goserelin acetate • Firmagon (degarelix) • Xofigo (radium Ra-223 dichloride) • leuprolide acetate for depot suspension
26d
ADJUVANT WIDER: Phase IIIb Study of Ribociclib + ET in Early Breast Cancer (clinicaltrials.gov)
P3, N=3100, Suspended, Novartis Pharmaceuticals | Recruiting --> Suspended
Trial suspension
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
ER positive • HER-2 negative • PGR positive
|
Kisqali (ribociclib) • letrozole • exemestane • goserelin acetate • leuprolide acetate for depot suspension
27d
New P2 trial • Metastases
|
Xtandi (enzalutamide capsule) • abiraterone acetate • Nubeqa (darolutamide) • Erleada (apalutamide) • triptorelin • goserelin acetate • Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension
27d
Comparison of the Therapeutic Effects of Vaginal Repair With Leuprorelin and Vaginal Repair in the Treatment of Cesarean Section Scar Defect (clinicaltrials.gov)
P=N/A, N=94, Recruiting, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Not yet recruiting --> Recruiting
Enrollment open
|
leuprolide acetate for depot suspension
1m
Trial completion • HEOR • Combination therapy
|
HER-2 (Human epidermal growth factor receptor 2)
|
Herceptin (trastuzumab) • paclitaxel • tamoxifen • Perjeta (pertuzumab) • cyclophosphamide • letrozole • epirubicin • anastrozole • exemestane • goserelin acetate • leuprolide acetate for depot suspension
1m
Micro RNAs to Predict Response to Androgen Deprivation Therapy (clinicaltrials.gov)
P=N/A, N=42, Active, not recruiting, Medical College of Wisconsin | N=60 --> 42
Enrollment change
|
docetaxel • Xtandi (enzalutamide capsule) • abiraterone acetate • bicalutamide • Erleada (apalutamide) • triptorelin • goserelin acetate • leuprolide acetate for depot suspension
2ms
New P2 trial
|
leuprolide acetate for depot suspension • Airui'en (rezvilutamide)
2ms
Immunoprofiles and Oncologic Outcomes of 15 Patients with Androgen Receptor-Positive Salivary Duct Carcinoma. (PubMed, Cancers (Basel))
Despite only including AR+ SDC of the parotid, immunoprofiles, such as expression of HER-2, were highly variable, highlighting the potential to tailor systemic regimens based on individual histologic profiles in the future. Studies with larger patient numbers using tumor-specific molecular profiling and tumor heterogeneity analyses are justified to better understand the biology of these tumors. Molecularly informed treatment approaches, including the potential use of AR- and HER-2/Neu-directed therapies upfront in the definitive setting, may hold future promise to further improve outcomes for these patients.
Journal
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AR (Androgen receptor)
|
HER-2 expression • AR positive
|
Herceptin (trastuzumab) • bicalutamide • leuprolide acetate for depot suspension
2ms
A Neoadjuvant Study of Abiraterone Acetate, Leuprolide Acetate, and Belzutifan in Men With Regional Prostate Cancer (clinicaltrials.gov)
P2, N=0, Withdrawn, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | N=30 --> 0 | Not yet recruiting --> Withdrawn
Enrollment change • Trial withdrawal
|
abiraterone acetate • Welireg (belzutifan) • leuprolide acetate for depot suspension
2ms
Transcriptome profiling reveals superovulation with the gonadotropin-releasing hormone agonist trigger impaired embryo implantation in mice. (PubMed, Front Endocrinol (Lausanne))
Mice in the superovulation (PG) group were administered 7.5 IU of PMSG, followed by the injection of 3.5 μg of GnRHa (Leuprorelin) 48 h later, while mice in the control group (CTR) mated naturally...The transcriptome analysis showed that superphysiological estrogen led to a response of the uterus to a high estrogen signal, resulting in abnormal endometrium and extracellular matrix remodeling and up-regulation of ion transport and inflammation-related genes. Our findings suggest that a combination of PMSG and GnRHa trigger impaired embryo implantation in mice, as the excessive uterine response to superphysiological estrogen levels can lead to the change of gene expression related to endometrial remodeling, abnormal expression of uterine ion transport genes and excessive immune-related genes.
Preclinical • Journal
|
LIF (LIF Interleukin 6 Family Cytokine)
|
leuprolide acetate for depot suspension
2ms
Enrollment change • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • AR (Androgen receptor)
|
HER-2 positive • HER-2 amplification • HER-2 mutation • AR positive
|
trastuzumab rezetecan (SHR-A1811) • leuprolide acetate for depot suspension • Airui'en (rezvilutamide) • SHR-A1921
3ms
Comparison Elagolix vs Depot Leuprolide Prior to Frozen Embryo Transfers in Patients With Endometriosis (clinicaltrials.gov)
P1, N=30, Active, not recruiting, Colorado Center for Reproductive Medicine | Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Sep 2023 --> Sep 2024
Enrollment closed • Trial completion date • Trial primary completion date
|
leuprolide acetate for depot suspension
3ms
ADJUVANT WIDER: Phase IIIb Study of Ribociclib + ET in Early Breast Cancer (clinicaltrials.gov)
P3, N=3100, Recruiting, Novartis Pharmaceuticals | Not yet recruiting --> Recruiting
Enrollment open
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
ER positive • HER-2 negative • PGR positive
|
Kisqali (ribociclib) • letrozole • exemestane • goserelin acetate • leuprolide acetate for depot suspension
3ms
ADJUVANT WIDER: Phase IIIb Study of Ribociclib + ET in Early Breast Cancer (clinicaltrials.gov)
P3, N=3100, Not yet recruiting, Novartis Pharmaceuticals | Trial primary completion date: Jul 2028 --> Sep 2029
Trial primary completion date
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
ER positive • HER-2 negative • PGR positive
|
Kisqali (ribociclib) • letrozole • exemestane • goserelin acetate • leuprolide acetate for depot suspension
3ms
A Study of Leuprolide Acetate Depot in Children With Central Precocious Puberty (clinicaltrials.gov)
P4, N=80, Recruiting, Takeda | Trial completion date: Apr 2024 --> May 2025 | Trial primary completion date: Jan 2024 --> May 2025
Trial completion date • Trial primary completion date
|
leuprolide acetate for depot suspension
3ms
SAVE: Radiotherapy Combined With a LHRH (Ant)Agonist Versus Apalutamide in Patients With Biochemical Recurrence After RP (clinicaltrials.gov)
P2, N=202, Recruiting, Cancer Research Antwerp | Trial completion date: Sep 2022 --> Dec 2025 | Trial primary completion date: Dec 2021 --> Aug 2025
Trial completion date • Trial primary completion date • Combination therapy
|
Erleada (apalutamide) • triptorelin • goserelin acetate • Firmagon (degarelix) • leuprolide acetate for depot suspension
3ms
First Strike, Second Strike Therapies for High Risk Metastatic Castration Sensitive Prostate Cancer (clinicaltrials.gov)
P2, N=31, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Phase classification: P2a --> P2 | Trial completion date: May 2026 --> Jan 2027 | Trial primary completion date: May 2025 --> Jan 2027
Phase classification • Trial completion date • Trial primary completion date • Metastases
|
docetaxel • Tevimbra (tislelizumab) • Xtandi (enzalutamide capsule) • abiraterone acetate • triptorelin • Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension
3ms
Addressing the risk and management of cardiometabolic complications in prostate cancer patients on androgen deprivation therapy and androgen receptor axis-targeted therapy: consensus statements from the Hong Kong Urological Association and the Hong Kong Society of Uro-Oncology. (PubMed, Front Oncol)
The panel reached a consensus on 18 statements based on recent evidence and expert insights. These consensus statements serve as a practical recommendation for clinicians in Hong Kong, and possibly the Asia-Pacific region, in the management of cardiometabolic toxicities of ADT or AR axis-targeted therapies in men with PCa.
Review • Journal
|
AR (Androgen receptor)
|
Xtandi (enzalutamide capsule) • abiraterone acetate • Nubeqa (darolutamide) • Erleada (apalutamide) • Firmagon (degarelix) • leuprolide acetate for depot suspension
3ms
RecoverPC: Relugolix vs GnRH Agonist in Quality of Life (clinicaltrials.gov)
P2, N=110, Recruiting, Dana-Farber Cancer Institute | Not yet recruiting --> Recruiting
Enrollment open
|
Orgovyx (relugolix) • leuprolide acetate for depot suspension
3ms
Clinical Trial of Rapid Progressive Central Precocious Puberty With Integrative Chinese and Western Medicine (clinicaltrials.gov)
P4, N=126, Completed, Children's Hospital of Fudan University | Recruiting --> Completed
Trial completion
|
megestrol • leuprolide acetate for depot suspension
4ms
Docetaxel, Radiation Therapy, and Hormone Therapy in Treating Patients With Locally Advanced Prostate Cancer (clinicaltrials.gov)
P1, N=20, Completed, Medical University of South Carolina | Active, not recruiting --> Completed
Trial completion
|
docetaxel • bicalutamide • goserelin acetate • leuprolide acetate for depot suspension
4ms
REPLACE-CV: Randomized Study to Evaluate MACE in Patients With Prostate Cancer Treated With Relugolix or Leuprolide Acetate (clinicaltrials.gov)
P3, N=2250, Active, not recruiting, Myovant Sciences GmbH | Recruiting --> Active, not recruiting
Enrollment closed • Adverse events
|
Orgovyx (relugolix) • leuprolide acetate for depot suspension
4ms
New P2 trial
|
docetaxel • cyclophosphamide • triptorelin • goserelin acetate • leuprolide acetate for depot suspension
4ms
Estrogen-induced glial IL-1β mediates extrinsic retinal ganglion cell vulnerability in murine Nf1 optic glioma. (PubMed, Ann Clin Transl Neurol)
In contrast to their male counterparts, female Nf1 mice have increased expression of glial interleukin-1β (IL-1β), which is neurotoxic to RGCs in vitro. Importantly, both IL-1β neutralization and leuprolide-mediated estrogen suppression decrease IL-1β expression and ameliorate RGC dysfunction, providing preclinical proof-of-concept evidence supporting novel neuroprotective strategies for NF1-OPG-induced vision loss.
Preclinical • Journal
|
NF1 (Neurofibromin 1) • IL1B (Interleukin 1, beta)
|
leuprolide acetate for depot suspension
4ms
Pre-Exposure Prophylaxis (PrEP)- Gender Affirming Hormone Therapy (GAHT) Interactions in TGW (clinicaltrials.gov)
P1, N=20, Recruiting, Johns Hopkins University | Trial completion date: Jun 2024 --> Jun 2025 | Trial primary completion date: Mar 2024 --> Mar 2025
Trial completion date • Trial primary completion date
|
leuprolide acetate for depot suspension
5ms
Palifermin With Leuprolide Acetate for the Promotion of Immune Recovery Following Total Body Irradiation Based T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation (clinicaltrials.gov)
P2, N=82, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
Trial completion date • Trial primary completion date
|
CD34 (CD34 molecule) • CD4 (CD4 Molecule)
|
Chr t(15;17)
|
cyclophosphamide • Firmagon (degarelix) • thiotepa • leuprolide acetate for depot suspension • Kepivance (palifermin)
5ms
NePtune: Study of Neoadjuvant PARP Inhibition Followed by Radical Prostatectomy in Patients With Unfavorable Intermediate-Risk or High-Risk Prostate Cancer With BRCA1/2 Gene Alterations (clinicaltrials.gov)
P2, N=32, Recruiting, Rana McKay, MD | Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Dec 2023 --> Dec 2025
Trial completion date • Trial primary completion date
|
BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
|
Lynparza (olaparib) • triptorelin • goserelin acetate • leuprolide acetate for depot suspension
5ms
High-Dose Brachytherapy in Treating Patients With Prostate Cancer (clinicaltrials.gov)
P=N/A, N=163, Active, not recruiting, Stanford University
Trial completion date
|
bicalutamide • triptorelin • goserelin acetate • Firmagon (degarelix) • leuprolide acetate for depot suspension
5ms
Systemic therapies for salivary gland carcinomas: an overview of published clinical trials. (PubMed, Med Oral Patol Oral Cir Bucal)
Despite all the advances in this field, there is yet no effective evidence-based regimen of ST, with all the clinical trials identified showing low rates of complete and partial responses. Further, translational studies are urgently required to characterize molecular targets and effective ST.
Journal
|
AR (Androgen receptor)
|
AR positive
|
sunitinib • leuprolide acetate for depot suspension
5ms
RecoverPC: Relugolix vs GnRH Agonist in Quality of Life (clinicaltrials.gov)
P2, N=110, Not yet recruiting, Dana-Farber Cancer Institute | Initiation date: Aug 2023 --> Jan 2024
Trial initiation date • HEOR
|
Orgovyx (relugolix) • leuprolide acetate for depot suspension
5ms
Trial completion
|
leuprolide acetate for depot suspension
5ms
Outcomes of men with high-risk biochemically recurrent prostate cancer who suspended enzalutamide monotherapy treatment in the phase 3 EMBARK study. (ASCO-GU 2024)
Clinical Trial Registration Number: NCT02319837 Sponsored by The study was sponsored by Pfizer Inc. In pts with high-risk BCR who suspended tx, the tx effect on MFS with enza mono was not different compared with leuprolide alone, though more pts reached tx suspension criteria with enza mono. However, in the no suspension group, enza mono prolonged MFS vs leuprolide alone, though the number of MFS events was limited (n=4). Pts with prior RP were also more likely to reach the PSA threshold for tx suspension.
P3 data
|
Xtandi (enzalutamide capsule) • leuprolide acetate for depot suspension
6ms
Trial completion date • Trial primary completion date
|
BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
|
Lynparza (olaparib) • triptorelin • goserelin acetate • leuprolide acetate for depot suspension
6ms
Density Lowering Effect of "OFS Add on to TMX"(DELFINO Trial) (clinicaltrials.gov)
P3, N=224, Recruiting, Seoul National University Hospital | Trial completion date: Oct 2023 --> Dec 2024 | Trial primary completion date: Sep 2023 --> Dec 2024
Trial completion date • Trial primary completion date
|
tamoxifen • goserelin acetate • leuprolide acetate for depot suspension
6ms
Brown Adipose Tissue Activity in Pre- and Postmenopausal Women (clinicaltrials.gov)
P=N/A, N=72, Completed, University of Colorado, Denver | Recruiting --> Completed | Trial completion date: Aug 2023 --> May 2023 | Trial primary completion date: Aug 2023 --> May 2023
Trial completion • Trial completion date • Trial primary completion date
|
leuprolide acetate for depot suspension
6ms
Enrollment closed • Enrollment change • Metastases
|
HRD (Homologous Recombination Deficiency)
|
Xtandi (enzalutamide capsule) • Rubraca (rucaparib) • goserelin acetate • Firmagon (degarelix) • leuprolide acetate for depot suspension